Updated report issued by HC
Vascular Biogenics, Ltd. (VBLT) / Swayampakula Ramakanth, Ph.D.
Price: $6.15; Market Cap (MM): $183; Rating: Buy; Target Price: $11.00
GLOBE Readout in March Could Herald a New Standard in GBM Therapy; Reiterate Buy Click here for full report
Topline results from the pivotal Phase 3 GLOBE study expected next month. With topline results from the GLOBE study expected in the near term, we present the potential scenarios and our thoughts on the study. Recall, the Phase 3 GLOBE study is a 256-patient randomized, controlled study that is evaluating the combination of VB-111 (ofranergene obadenovec) with Avastin (bevacizumab, marketed by Roche (RHHBY; not rated)) against Avastin alone in the treatment of recurrent GBM (rGBM). The study completed patient enrollment in December 2016 and readout of topline results is scheduled to occur after 75% of patient events, which we expect to happen in the second half of March. The primary outcome measure of the study is overall survival (OS). In the previous Phase 2 study, patients treated with VB-111 plus Avastin achieved a median OS of 15 months, compared to historical OS of 9-12 months for Avastin alone. We believe that if the VB-111 cohort can replicate the success of Phase 2 study and achieve a similar OS, then the VB-111 plus Avastin combination could become the new standard of care for this difficult to treat indication. Management has indicated that beyond topline OS, other predefined survival endpoints include: 1) OS stratified by the size of the tumor (medium > 15 ml; large > 32 ml); 2) OS at 12 months; and 3) OS for patients who survive at least 100 days (excluding rapid progressors). According to management, all predefined endpoints are included in the Special Protocol Assessment (SPA) that was reviewed by the FDA. Specifically, the last endpoint (OS for patients survived 100 days) was included under the rationale that it could take a considerable amount of time for the drug-induced immune response to reach its full-scale effect. Additional secondary endpoints of the GLOBE study include progression-free survival and tumor response (as measured by RANO criteria). Taken together, we have an optimistic view on the anticipated GLOBE results, and we believe that the inclusion of additional surrogate survival endpoints help mitigate downside risk, acting as a safety cushion for investors.
GLOBE study design helps to mitigate potential downside.
What to expect from VB-111 beyond GBM.
Valuation and risks.
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